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Randomized Controlled Trial
. 2008 Jul 28;14(28):4492-8.
doi: 10.3748/wjg.14.4492.

Folic acid supplementation inhibits recurrence of colorectal adenomas: a randomized chemoprevention trial

Richard Jaszewski  1 , Sabeena Misra, Martin Tobi, Nadeem Ullah, Jo Ann Naumoff, Omer Kucuk, Edi Levi, Bradley N Axelrod, Bhaumik B Patel, Adhip P N Majumdar
Affiliations
Randomized Controlled Trial

Folic acid supplementation inhibits recurrence of colorectal adenomas: a randomized chemoprevention trial

Richard Jaszewski et al. World J Gastroenterol. .

Abstract

Aim: To determine whether folic acid supplementation will reduce the recurrence of colorectal adenomas, the precursors of colorectal cancer, we performed a double-blind placebo-controlled trial in patients with adenomatous polyps.

Methods: In the current double-blind, placebo-controlled trial at this VA Medical Center, patients with colorectal adenomas were randomly assigned to receive either a daily 5 mg dose of folic acid or a matched identical placebo for 3 years. All polyps were removed at baseline colonoscopy and each patient had a follow up colonoscopy at 3 years. The primary endpoint was a reduction in the number of recurrent adenomas at 3 years.

Results: Of 137 subjects, who were eligible after confirmation of polyp histology and run-in period to conform compliance, 94 completed the study; 49 in folic acid group and 45 in placebo group. Recurrence of adenomas at 3-year was compared between the two groups. The mean number of recurrent polyps at 3-year was 0.36 (SD, 0.69) for folic acid treated patients compared to 0.82 (SD, 1.17) for placebo treated subjects, resulting in a 3-fold increase in polyp recurrence in the placebo group. Patients below 70 years of age and those with left-sided colonic adenomas or advanced adenomas responded better to folic acid supplementation.

Conclusion: High dose folic acid supplementation is associated with a significant reduction in the recurrence of colonic adenomas suggesting that folic acid may be an effective chemopreventive agent for colorectal neoplasia.

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Figures

Figure 1
Figure 1
Number of adenomas versus treatment. Histograms showing the number of adenomas or all types of polyps in folic acid and placebo-treated groups at baseline and 3 years after treatment. 1P = 0.02514, compared to the placebo-treated group. Each histogram represents the mean ± SD.
Figure 2
Figure 2
Polyp characteristics and response to treatment. Recurrence of advanced [large (> 1 cm) and polyps with villous component] or non-advanced adenomas (upper panel) as well as right or left-sided adenomas (lower panel) following 3 years of treatment with a high dose of folic acid. The numbers of subjects as well as the levels of significance between the two groups are shown.
Figure 3
Figure 3
The effect of age on the response to treatment. Recurrence of adenomas in response to 3 years of folic acid treatment in patients over or below 70 years of age in shown. The number of subjects in each group as well as the levels of significance is shown in the figure.
See this image and copyright information in PMC

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